openfda-mcp-server

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  <h1>@cyanheads/openfda-mcp-server</h1>
  <p><b>Query FDA data on drugs, food, devices, and recalls via openFDA. STDIO or Streamable HTTP.</b>
  <div>14 Tools</div>
  </p>
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**Public Hosted Server:** [https://openfda.caseyjhand.com/mcp](https://openfda.caseyjhand.com/mcp)

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---

## Tools

Fourteen tools for querying FDA data across drugs, food, devices, animal/veterinary products, and recalls — plus an optional DataCanvas SQL surface for large result sets:

| Tool | Description |
|:---|:---|
| `openfda_drug_profile` | One drug name → consolidated FDA profile: identity, label, adverse events, recalls, approval, shortage |
| `openfda_search_adverse_events` | Search adverse event reports across drugs, food, and devices |
| `openfda_search_animal_events` | Search adverse event reports for veterinary drugs and devices |
| `openfda_search_drug_shortages` | Search FDA drug shortage records — status, availability, therapeutic category, manufacturer |
| `openfda_search_tobacco_reports` | Search problem reports for tobacco products, e-cigarettes, and vaping devices |
| `openfda_search_recalls` | Search enforcement reports and recall actions across drugs, food, and devices |
| `openfda_count_values` | Aggregate and tally unique values for any field across any openFDA endpoint |
| `openfda_describe_fields` | Return searchable field paths for an openFDA endpoint, grouped by category |
| `openfda_get_drug_label` | Look up FDA drug labeling (package inserts / SPL documents) |
| `openfda_search_drug_approvals` | Search the Drugs@FDA database for NDA/ANDA application approvals |
| `openfda_search_device_clearances` | Search FDA device premarket notifications — 510(k) clearances and PMA approvals |
| `openfda_lookup_ndc` | Look up drugs in the NDC (National Drug Code) Directory |
| `openfda_dataframe_query` | Run read-only SQL over a result set staged on a DataCanvas (opt-in) |
| `openfda_dataframe_describe` | List tables and column schemas staged on a DataCanvas (opt-in) |

**The nine record-returning tools bound their page at ~24 KB.** openFDA record size is not something a caller can see in advance — a `drug/event` report averages ~34 KB against ~440 bytes for a `food/event` report, so `limit: 10` means very different things per endpoint. The eight multi-row search tools return as many records of the requested window as fit, then report the withheld count on `page_omitted` alongside the byte figure and the routes to the rest (the exact `skip` to continue from, a lower `limit`, `stage: true` for SQL, or `openfda_count_values` for a distribution). Whenever anything matched, at least one record comes back, whatever it measures. `openfda_get_drug_label` returns a section outline instead, since its payload is one document rather than many rows.

### `openfda_drug_profile`

Resolve one drug name to its FDA identity, then return a consolidated profile in a single call — replacing four or five chained lookups.

- Resolves a brand or generic name to canonical FDA identifiers once (generic name, NDC, RxCUI, SPL set ID), then keys every sub-query off that identity to avoid the identifier drift that breaks naive tool chaining
- Single-ingredient resolution: a single-drug query won't resolve to a combination product
- Sections: label highlights, adverse-event summary (top reactions, serious count), recall history, Drugs@FDA approval, and current shortage status
- Best-effort — a miss on any section returns `null` rather than failing the whole call; use the dedicated tool for a deep dive into any area

---

### `openfda_search_adverse_events`

Search adverse event reports across drugs, food, and devices. Use to investigate safety signals, find reports for a specific product, or explore reactions by demographics.

- Category selection: `drug`, `food`, or `device` — each returns different field schemas
- Elasticsearch query syntax for filtering by product, reaction, seriousness, date range
- Pagination via `limit` (up to 1000) and `skip` (openFDA's ceiling is 25000 — past it the call returns a typed `pagination_limit_reached` error with recovery guidance)
- `drug/event` is the largest-record endpoint openFDA serves, so this is where the ~24 KB page budget bites hardest: a default `limit: 10` on drug reports typically returns one to three of them with the rest disclosed on `page_omitted`, where the same call on food reports returns all ten
- Formatted output includes report ID, seriousness, patient demographics, reactions, drugs with characterization/indication/route, and all remaining fields

---

### `openfda_count_values`

Aggregate and tally unique values for any field across any openFDA endpoint. Returns ranked term-count pairs sorted by count descending.

- Works across all 20 openFDA endpoints (drugs, food, devices, animal/veterinary, tobacco, other)
- Use `.exact` suffix on field names for whole-phrase counting
- Optional `search` filter to scope the aggregation
- Returns up to 1000 terms per query

---

### `openfda_search_recalls`

Search enforcement reports and recall actions across drugs, food, and devices.

- Supports `enforcement` (all categories) and `recall` (devices only) endpoints
- Filter by classification (Class I/II/III), recalling firm, reason, status
- Formatted output includes recall number, classification, product description, reason, distribution pattern

---

### `openfda_search_device_clearances`

Search FDA device premarket notifications — 510(k) clearances and PMA approvals.

- Two pathways: `510k` (174K+ records, most common) and `pma` (higher-risk devices)
- Filter by applicant, product code, advisory committee, device name
- Formatted output adapts to pathway: 510(k) shows K-number/clearance type, PMA shows supplement info

---

### `openfda_get_drug_label`

Look up FDA drug labeling (package inserts / SPL documents). Check indications, warnings, dosage, contraindications, active ingredients, or any structured label section.

- Search by brand name, generic name, manufacturer, or set ID
- Formatted output dynamically renders all label sections and openfda metadata present in the record, in full — `content[]` and `structuredContent` carry the same text
- A page over the ~24 KB inline budget returns `kind: "outline"` — the section names and their sizes — instead of the label text; re-call with `sections: [...]` for the ones you need
- Outline sizes are summed across the page, so a section's cost scales with `limit` — the re-call guidance names a section measured to fit the budget at the requested limit and quotes its byte size
- `sections` narrows each record to the requested keys plus metadata (`openfda`, `set_id`, `id`, `effective_time`, `version`); a selection over the budget is returned whole, never trimmed, with its serialized size reported
- Default limit of 5 — labels are large documents (a warfarin label is ~130 KB on its own)

---

### `openfda_search_drug_approvals`

Search the Drugs@FDA database for drug application approvals (NDAs and ANDAs). Returns application details, sponsor info, and full submission history.

- Filter by brand name, sponsor, submission type, review priority
- Formatted output includes products with active ingredients, dosage forms, routes, and marketing status
- Full submission history with type, status, date, and review priority
- Pagination via `limit` (up to 1000) and `skip` (openFDA's ceiling is 25000 — past it the call returns a typed `pagination_limit_reached` error with recovery guidance)

---

### `openfda_lookup_ndc`

Look up drugs in the NDC (National Drug Code) Directory. Identify drug products by NDC code, find active ingredients, packaging details, or manufacturer info.

- Search by product NDC, brand name, generic name, manufacturer, or active ingredient
- Returns product details, active ingredients with strengths, and packaging information
- Sortable by listing expiration date or other fields

---

### `openfda_search_animal_events`

Search adverse event reports for veterinary drugs and devices submitted to the FDA Center for Veterinary Medicine (1.3M+ records).

- Filter